melanoma skin cancer
Conditions
Interventions
Treatment with recNY-ESO-1+AS15 ASCI.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment. 2. Written informed consent for NY-ESO-1 expression screening and gene profiling on resected tumor tissue and for the complete study has been obtained from the patient prior to shipment of the sample for expression testing and prior to the performance of any other protocol-specific procedure. 3. Patient is > or = 18 years of age at the time the informed consent form is signed. 4. The patient*s tumor shows expression of NY-ESO-1, as determined by real-time quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis or any updated technique on fresh tissue sample(s). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. The patient has normal organ functions, including hemoglobin, leukocytes, lymphocytes, platelets, serum creatinine, serum total bilirubin, lactate dehydrogenase, ASAT, and ALAT. 7. Female patients of non-childbearing potential may be enrolled in the study. 8. Female patient of childbearing potential may be enrolled in the study if adequate contraception is being practiced and pregnancy tests are negative. 9. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. The patient has at any time received systemic chemotherapy, biochemotherapy or anti-CTLA-4 monoclonal antibody for metastatic disease. 2. The patient is scheduled to receive any other anticancer treatments than those specified in the protocol, including but not limited to (bio-)chemotherapeutic, immunomodulating agents and radiotherapy. 3. The patient received any cancer immunotherapy containing a NY-ESO-1 antigen or any cancer immunotherapy for his/her metastatic disease. 4. The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents. 5. Use of any investigational or non-registered product (drug or vaccine) other than the ASCI within 30 days preceding the first ASCI administration, or planned use during the study period. 6. The patient has (had) previous or concomitant malignancies at other sites (including carcinoma in situ), except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. 7. The patient has an allergy to any component of the study investigational product or has a history of previous allergic reactions to vaccinations. 8. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded. 9. The patient has a family history of congenital or hereditary immunodeficiency. 10. The patient is known to be positive for the Human Immunodeficiency Virus (HIV). 11. The patient has an uncontrolled bleeding disorder. 12. The patient has a family history of congenital or hereditary immunodeficiency. 13. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures. 14. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. 15. For female patients: the patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of severe toxicities during the study treatment phase and follow-up. The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective clinical response (CR or PR) in the population of patients who present the predictive MAGE-A3 gene signature. In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: stable disease (SD), mixed response (MR), Time to Treatment Failure (TTF, the time from first treatment until the date of the last treatment administration), progression-free survival (PFS), overall survival (OS), duration of response for patients with CR, PR or Stable Disease (SD) status. Side effects. Anti-NY-ESO-1 antibody concentration and response. Anti-NY-ESO-1 cellular (T-cell) response. As of Amendment 3, there will no longer be an active follow-up of patients after discontinuation of completion of the treatment. The study will end 30 days after the last dose will be administered. In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant. Blood sampling for safety monitoring as per protocol will continue. | — |
Countries
Netherlands
Outcome results
None listed